Device recall
Z-0169-2014: VitreaCore software. Versions subject to the limitation: 6.0, 6.1, 6.2, 6.3…
FDA device recall · Class II · Vital Images, Inc.
Key facts
| Recall number (Z-number) | Z-0169-2014 |
|---|---|
| Recall event | 66659 |
| Product | VitreaCore software. Versions subject to the limitation: 6.0, 6.1, 6.2, 6.3 (except 6.3.1 ), 6.4 (except 6.4.4 and 6.4.5), as well as their upgrades, and 6.5. The VitreaCore (ViTALConnect) system is a medical diagnostic software system intended to process, analyze, review, and distribute… |
| Product code | LLZ |
| Recalling firm | Vital Images, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jan 16, 2015 |
| 510(k) numbers | K062154, K071362 |
| FEI number | 3001654007 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 100–999 Recalled products with this product code
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device recalls (products)
Each recalled device product receives a Z-number. Recall details such as root cause, distribution and firm actions are available in Orca1.
Source: U.S. Food and Drug Administration (FDA), Medical Device Recalls database